Clinical trial · Interventional
Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated. Eisai's Targretin acquired by another pharmaceutical company.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bexarotene | Drug | Bexarotene | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Bexarotene
Primary outcomes (1)
- measure
- Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy.
- timeFrame
- Two months after 17th patient has started treatment with Bexarotene, for up to 1 year
- description
- Hematologic response will be assessed according to modified criteria of an international working group defined by Cheson et al, Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood, 1 December 2000, Vol. 96, No. 12, pp. 3671-3674
Secondary outcomes (1)
- measure
- Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years * Confirmed diagnosis of AML as proven by bone marrow biopsy * Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not eligible for conventional chemotherapy * ECOG performance status of 0-2 * Recovered from toxicities of prior chemotherapy Exclusion Criteria: * History of pancreatitis * Active alcohol abuse * Taken bexarotene in the past * WBC \> 10,000/uL at time of enrollment * Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose Mylotarg * Significant organ disfunction: total bilirubin \> 3x ULN, AST or ALT \>3 x ULN, creatinine \> 3 mg/dL, on blood pressure supporting medications or mechanical ventilation * Active participant in any other investigational treatment study for AML * Life expectancy of less than 1 month * Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega) within 1 week prior to treatment initiation * Uncontrolled hyperlipidemia * Known history of HIV * Known active CNS involvement with AML * Women of childbearing potential or active breast feeding
References
Publications (0)
Data not yet available